PLYMOUTH, Minn., April 16 /PRNewswire-FirstCall/ -- ev3 Inc. (Nasdaq:
EVVV) announced today it has received Humanitarian Device Exemption (HDE)
approval from the U.S. Food and Drug Administration (FDA) for its Onyx HD
500 Liquid Embolic System for the treatment of intracranial aneurysms. This
approval allows ev3 to commercialize its Onyx Liquid Embolic System to a
population of patients with wide-necked cerebral aneurysms. The approval is
limited to saccular, sidewall aneurysms with a dome to neck ratio less than
2 mm that are not amenable to treatment with surgical clipping. ev3's Onyx
18 and 24 Liquid Embolic System received FDA approval in July of 2005 for
the treatment of cerebral arteriovenous malformations.
(Logo: http://www.newscom.com/cgi-bin/prnh/20050615/CGEV3LOGO )
Jim Corbett, CEO of ev3, commented, "We are delighted with the HDE
approval of Onyx HD 500 as it provides physicians a new clinical tool to
treat patients with wide-neck cerebral aneurysms who have very few
therapeutic options. This approval further documents the unique therapeutic
profile of our Onyx technology platform."
Cerebral aneurysms are vascular abnormalities in the brain that are
characterized by a bulge in the wall of a blood vessel. These defects can
cause severe neurologic symptoms, including death in the case of a rupture.
A U.S. Investigational Device Exemption study and two European clinical
studies closely examined the treatment of nearly 200 aneurysms,
demonstrating that patients with wide-necked aneurysms were effectively
treated with the Onyx HD 500 Liquid Embolic System. Wide-necked aneurysms
occur in approximately 20% of the 17,000 patients that are treated each
year in the United States with embolic coils.
Onyx HD 500 will be marketed in the United States by the ev3
Neurovascular sales force. As the first liquid embolic to be approved for
the treatment of cerebral aneurysms, the release of Onyx HD 500 will be
preceded by a lengthy period of education and training for a small group of
leading neurovascular specialists. Once trained, this group of proctors
will help insure that the use of Onyx HD 500 is carefully controlled as is
required for all HDE approved devices.
About ev3 Inc.
ev3 is a global medical device company focused on catheter-based
technologies for the endovascular treatment of vascular diseases and
disorders. For more information, please visit http://www.ev3.net.
Statements contained in this press release that are not historical
information are forward-looking statements as defined within the Private
Securities Litigation Reform Act of 1995. Such forward-looking statements
are subject to risks and uncertainties that could cause actual results to
differ materially from those projected or implied. Such potential risks and
uncertainties relate, but are not limited to, in no particular order:
product demand and market acceptance, the impact of competitive products
and pricing, and success of clinical testing. More detailed information on
these and additional factors which could affect ev3 Inc.'s operating and
financial results are described in the company's filings with the
Securities and Exchange Commission, including its most recent annual report
on Form 10-K. ev3 Inc. urges all interested parties to read this report to
gain a better understanding of the many business and other risks that the
company faces. Additionally, ev3 Inc. undertakes no obligation to publicly
release the results of any revision to these forward-looking statements,
which may be made to reflect events or circumstances occurring after the
date hereof or to reflect the occurrence of unanticipated events.
ev3 and the ev3 logo are trademarks of ev3 Inc., registered in the U.S.
and other countries. All trademarks and tradenames referred to in this
press release are the property of their respective owners.
SOURCE ev3 Inc.
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Related links:
http://www.ev3.net
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20050615/CGEV3LOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Investor Relations: Patrick Spangler, CFO for
ev3 Inc., +1-763-398-7000, pspangler@ev3.net; or Media: Laura
Nobles of Nobles Communications, +1-310-795-0497, +1-310-338-8595
(fax), laura@noblescommunications.com
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